Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

Phase 3

Withdrawn

• Conditions: Leber's Hereditary Optic Neuropathy
• Interventions: Drug: Idebenone; Drug: Placebo

• Registration Number: NCT01495715
• Lead Sponsor: Santhera Pharmaceuticals

Brief Summary

The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-20
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age > or equal 10 years and < 65 years
• Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
• No explanation for visual loss besides LHON

Exclusion Criteria

• Any previous use of idebenone
• Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
• Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idebenone	Idebenone	-
Placebo	Placebo	-